A Phase II Trial of Intermediate Radiation Dose For Lymphoma

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05284825
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma.

It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months.

This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma	Radiation: 12 Gy in 6 daily fractions	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Intermediate Radiation Dose For Low Grade Follicular Lymphoma
• Actual Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 12 Gy in 6 daily fractions	Radiation: 12 Gy in 6 daily fractions; 12 Gy in 6 daily fractions

Outcome Measures

Primary Outcome Measures

1. Complete response within the radiated volume at 1month post radiation [1 month]

   Participants will be assessed for response at 1 month (primary outcome) and then 3 months following completion of radiotherapy, clinically or radiographically, as appropriate. Complete response is defined as absence of detectable disease in the radiated volume. Partial response is 50% or more reduction in the volume of disease in the radiated volume. Overall response is defined as complete and partial response. Stable disease is defined as no change in the irradiated tumour or less than 50% reduction. Progressive disease is defined as enlargement of the irradiated tumour

Secondary Outcome Measures

1. Overall survival, progression-free survival and toxicity [1 month and 3 month]

   Toxicity (6) will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) definitions (site specific modules), at 1 month and then 3 months following completion of radiotherapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• ≥ 18 years or older

• Pathology review at Sunnybrook Health Sciences Centre showing low grade (grade 1- 2) follicular lymphoma

• Previously un-irradiated stages I-IV low grade follicular lymphoma

• Radiation indicated for local disease control (radical or palliative)

• Able to give informed consent

• Non-bulky targets (less than 7cm)

Exclusion Criteria:

• Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy

• Prognosis less than 3 months

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre

Investigators

• Principal Investigator: May Tsao, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT05284825
• Other Study ID Numbers: 3744
• First Posted: Mar 17, 2022
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sunnybrook Health Sciences Centre: radiation
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Follicular

Study Results

No Results Posted as of Mar 17, 2022